DTaP-HB-PRP~T combined vaccine is being developed in order to comply with expanding programs for immunization in infancy, while offering the benefit of a reduced number of injections, and potentially of an increased acceptance.

Primary Objectives:

To describe the antibody persistence at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP~T or Tritanrix-Hep B/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hepatitis B (Hep B) vaccine given at birth.

To describe the effect of a booster dose of DTaP-HB-PRP~T on immunogenicity at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP~T or Tritanrix HepB/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hep B vaccine given at birth.

Secondary Objective:

To describe the safety profile of the booster dose of the DTaP-HB-PRP~T vaccine when administered concomitantly with Oral Polio Vaccine (OPV).

Immunogenicity Study of the Antibody Persistence and Booster Effect of DTaP-Hep B-PRP-T Combined Vaccine at 12 to 18 Months of Age Following a Primary Series at 6, 10 and 14 Weeks of Age in Healthy Filipino Infants Having Received Hepatitis B Vaccine at Birth

Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-booster vaccination ] [ Designated as safety issue: No ]

Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria following the booster vaccination.

Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) [ Time Frame: Day 0 to Day 7 after vaccination ] [ Designated as safety issue: No ]

This study will assess the immunogenicity and reactogenicity of the investigational DTaP-HB-PRP~T combined vaccine when given as a booster dose, concomitantly with OPV, in Filipino children previously primed at 6, 10, and 14 weeks with the investigational DTaP-HB-PRP~T combined vaccine or Tritanrix-Hep B/Hib™ vaccine and having received a first dose of Hep B vaccine (Recomvax B™) at birth in a previous study, AL201 (NCT00348881).

Eligibility

Ages Eligible for Study:

12 Months to 18 Months

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Toddler aged 12 to 18 months of age on the day of inclusion (range: 365 days to 578 days of age inclusive)

Participated in the AL201 study and completed the three-dose primary series with either DTaP-HB-PRP~T or Tritanrix-HepB/Hib™, and OPV, at 6, 10 and 14 weeks of age, and received hepatitis B vaccine at birth

Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)

Able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria:

Participation in another clinical trial in the 4 weeks preceding the trial vaccination

Planned participation in another clinical trial during the present trial period

Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term (for more than 2 weeks) systemic corticosteroid therapy within the preceding 3 months

Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances

Chronic illness at a stage that could interfere with trial conduct or completion

Blood or blood-derived products received in the last 3 months

Any vaccination in the 4 weeks preceding the trial vaccination

Vaccination planned in the 4 weeks following the trial vaccination

Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00514709